Dive Brief:
- The European Medicines Agency on Friday called for the suspension of marketing authorization for dozens of generic drugs that relied on bioequivalence studies from the India-based Semler Research Centre, after concluding the center's studies were flawed. The opinion will now be forwarded to the European Commission for final vote.
- The EMA's decision followed facility inspections by the Food and Drug Administration and World Health Organization which raised concerns over alleged data manipulation in the center's bioanalytical and clinical sites. Given the agencies' doubts over the center's data quality controls, the EMA concluded any bioequivalence studies conducted there were unacceptable unless backed by alternative studies.
- Bioequivalence studies are typically the basis for EMA approval of generic drugs. As a result, the EMA released a list of previously-approved drugs now recommended for suspension and a list of drugs that should remain on the market based on alternative proof of bioequivalence. EU member countries may, however, override suspension if the generic drug is deemed pivotal by the state.
Dive Insight:
The suspensions would mainly affect drugs based on atovaquone/proguanil (malaria), ebastine (antiallergenic), eletriptan (migraine) and erlotinib (metastatic cancer), and could potentially disrupt market sales for Israel's Teva, Switzerland's Novartis and Sweden's Mylan, among other global generics companies.
Teva, for example, sells copies of Roche's Tarceva (erlotinib) and GlaxoSmithKline's Malarone (atovaquone/proguanil) in Europe.
Generics companies can avoid suspension of their marketing authorizations by providing alternative proof of bioequivalency to the agency. Meanwhile, any drug currently submitted for marketing authorization using Semler studies will not be approved.
The EMA's recommendation could also have an impact on the perception of India's generic manufacturing market. The rebuke of the Semler facility's manufacturing practices come at a time of increased regulatory scrutiny of the quality of worldwide drug production facilities which has resulted in multiple plant closings and import bans for numerous Indian (and Chinese) firms.
The Semler facility is a contract research organization that conducts bioequivalence studies for medicines reviewed in the U.S., EU, and those included in the WHO prequalification program. The EMA review of the conditions Indian testing facility began April 2016 following the conclusion of FDA and WHO inspections that same month.
But a decision on the testing front could expand the impact of regulatory censure to include already approved drugs and negatively affect market partnerships between global companies and contracted facilities. Regulators hope the increased scrutiny will translate into stricter, self-enforced adherence to good manufacturing practices worldwide.